Document is current

Article History

First Online: 11 July 2019

Compliance with Ethical Standards

:

: This study was funded by Pfizer. Medical writing support was provided by Lorna Forse, PhD, of Engage Scientific Solutions and was funded by Pfizer.

: Professor Edwards has received honoraria for advisory boards and speakers’ bureau and research support from AbbVie, BMS, Biogen, Celgene, Fresenius, Janssen, Lilly, Mundipharma, Pfizer, MSD, Novartis, Roche, Samsung, Sanofi, and UCB. Ms. Roshak was an employee of Pfizer at the time of data generation and manuscript initiation. Dr. Thakur is an employee of RegSafe Consulting Limited and was contracted by Pfizer in connection with the development of the manuscript. Mr. Pedersen, Dr. Borlenghi, and Dr. Curiale are employees of and own stock in Pfizer. Dr. Bukowski, Ms. Jones, and Dr. Marshall were employees of Pfizer at the time of data generation and manuscript development and own stock in Pfizer.

: As a non-interventional study, ethical approval was not required for this analysis. This article does not contain any studies with human participants or animals performed by any of the authors.

: Upon request, and subject to certain criteria, conditions, and exceptions (seeExternalRef removedfor more information), Pfizer will provide access to individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines, and medical devices (1) for indications that have been approved in the USA and/or EU or (2) in programs that have been terminated (i.e., development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer.